- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03116646
The Reliability and Validity of Family Report Chewing Evaluation
May 31, 2020 updated by: SELEN SEREL ARSLAN, Hacettepe University
The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training.
Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents.
The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Chewing is a function that is defined as the grinding of solid food and making them ready for swallowing.
Chewing begins with the acceptance of solid food with the lips.
The rotational and lateral movements of the tongue is also necessary during grinding the solid food in the molar region.
In the molar region, grinding is carried out with the help of salivary and salivary enzymes.
Chewing behavior is a learned function.
The child begins to chew at 6 months and the coordinated movement to the 9th month continues to develop.
Together with experience, chewing activity continues to develop.
The families have a primary role in chewing training.
In some children, the chewing function does not develop as desired.
Many children with developmental, medical, or oral motor problems have difficulty in grinding and swallowing solid foods.
Therefore, it is very important to assess the ability of the child's chewing and determine the treatment goals.
Assessment of the child's ability to chew should begin by considering chewing as a function.
For this reason, the Karaduman Chewing Performance Scale (KCPS) was developed at the Hacettepe University, Faculty of Health Sciences Department of Physiotherapy and Rehabilitation.
The chewing performance of the child during chewing a biscuit is scored by the therapist between 0-4.
0 refers to normal chewing, 4 means no bite and chew.
The family has a primary prescription in the identification of the chewing disorder in children to plan appropriate rehabilitation program and implementation of the training.
Therefore, it is very important to investigate the validity and reliability of classification systems that can be applied by parents.
The purpose of this study is to determine the validity and reliability of the reliability and validity of family report chewing evaluation (Karaduman Chewing Performance Scale-Family report).
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey, 06100
- Hacetttepe University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children above the age of 18 months
- Children with chewing disorders
Exclusion Criteria:
- Children below the age of 18 months
- Children without chewing disorders
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Chewing evaluation
Children with chewing disorders will be recruited.
Each child is required to bite and chew a standardized biscuit for chewing evaluation.
The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist.
Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families.
|
Children with chewing disorders will be recruited.
Each child is required to bite and chew a standardized biscuit for chewing evaluation.
The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist.
Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chewing evaluation
Time Frame: 1 month
|
Each child is required to bite and chew a standardized biscuit for chewing evaluation.
The chewing function of each child is scored with the Karaduman Chewing Performance Scale.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2019
Primary Completion (Actual)
November 20, 2019
Study Completion (Actual)
November 20, 2019
Study Registration Dates
First Submitted
April 11, 2017
First Submitted That Met QC Criteria
April 13, 2017
First Posted (Actual)
April 17, 2017
Study Record Updates
Last Update Posted (Actual)
June 2, 2020
Last Update Submitted That Met QC Criteria
May 31, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Family report chewing function
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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